BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCH ANCHOR

    MDR report key: 1870538 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02133
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 17, 2008
    Report Date
    December 17, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED AND A NONCONFORMANCE WAS FOUND RELATED TO THE PRODUCT, HOWEVER THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. THE ANCHOR RETURNED APPEARS TO BE IN GOOD CONDITION. IN LAB, THE ANCHOR WAS TIED WITH 2.0 - SUTURE IN A FIXED POSITION WITH A TEST LEAD AND THE ANCHOR HELD THE LEAD AS DESIGNED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED ON (B)(6) 2008 THAT THERE WAS A LEAD MIGRATION DUE TO LEAD ANCHOR POSSIBLY NOT HOLDING CORRECTLY. THE LEAD ANCHOR WAS EXPLANTED AND RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCH ANCHOR SPINAL CORD STIMULATION ACCESSORY LGW ADVANCED NEUROMODULATION SYSTEMS 1194 119791

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention